For the whole decision click here: o30304
Summary
This is a statement of reasons issued following a decision given orally at the hearing.
The application concerned a treatment for Peyronie's disease (a condition characterised by formation of dense fibrous plaques in the penis) involving injection of a composition containing collagenase directly into the affected part. The prior art showed that collagenase was previously known for treating this condition, but not at the high concentrations and doses now specified.
A Swiss type claim was allowed covering use of a quantity of collegenase within a specified range in a pharmaceutically acceptable carrier and within a specified concentration range in the manufacture of a medicament for treating Peyronies disease.
Although specifying the dose and concentration of an active ingredient in an injectable composition would normally be considered to fall within the ambit of a method of treatment, which must be rejected under s. 2(6), the claim offered was nevertheless held to be allowable as relating to a new 'composition' on the grounds that: a medical practitioner at the relevant time would have not have considered using the claimed concentration as it would have been regarded as dangerously high; it was not technically possible to achieve the same results using multiple administration of the more dilute prior art compositions; and the invention was effective in treating patients who had not responded to the prior art compositions.